This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.

Eligibility

Ages Eligible for Study:

18 Years to 50 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Healthy adults aged 18 to 50 years

Resident in or near Dakar for the duration of the study

Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician

Willing to use effective contraception throughout duration of study (if female)

HIV antibody positive; diagnosed at least 6 months previously

CD4 count >300

Arm 1: HIV viral load not >100,000 copies per millilitre

Arm 2: Undetectable HIV viral load

Written informed consent

Exclusion Criteria:

Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis

Group 1 only: Any ARV therapy within the past 6 months

Previous history of TB disease and/or treatment

Any AIDS defining illness

Group 1: CD4 count nadir <300

Group 2: CD4 count nadir <100

CXR showing TB or evidence of other active infection

Prior receipt of a recombinant MVA or Fowlpox vaccine

Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period

Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products

Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine (including evidence of cardiovascular disease, history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), history of insulin requiring diabetes mellitus, any ongoing chronic illness requiring ongoing specialist supervision (e.g., gastrointestinal), and chronic or active neurological disease)

Any confirmed or suspected immunosuppressive or immunodeficient condition, other than HIV infection, such as asplenia

Evidence of hepatomegaly

Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate

Pregnant/lactating female and any female who is willing or intends to become pregnant during the study

Any history of anaphylaxis in reaction to vaccination

PI assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731471